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  5. Exemptions Relevant to Produce Farms Under the Produce Safety Rule and the Food Traceability Rule
  1. Food Safety Modernization Act (FSMA)

Exemptions Relevant to Produce Farms Under the Produce Safety Rule and the Food Traceability Rule

Back to FSMA Food Traceability Rule

This chart summarizes exemptions relevant to produce farms for the Produce Safety Rule (PSR) and the Food Traceability Rule (FTR). See the respective final rules (21 CFR Part 112 and 21 CFR Part 1, subpart S) for full descriptions of each exemption.

Please note that the FTR only applies to foods that appear on the Food Traceability List. In contrast, the PSR applies to all produce, unless the produce appears on the rarely consumed raw list or is otherwise described as not being covered by the PSR.

Food/Entity Produce Safety Rule Food Traceability Rule
Produce that is on the rarely consumed raw (RCR) list Produce is not covered Produce is exempt
Food (including produce) produced for personal consumption Produce is not covered Food (including produce) is exempt
Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance Produce is exempt, provided the conditions set forth in § 112.2(b) are met

Produce is exempt, provided that either:

  1. the conditions set forth in § 112.2(b) are met, or
  2. the requirements in § 1.1305(d)(6) for food that will receive a kill step are met
Average annual value of food sales to qualified end-users (as defined in § 112.3) exceeds average annual value of food sales to all other buyers, and average annual value of all food sold is less than $500,000, adjusted for inflation Farm is eligible for a qualified exemption and associated modified requirements as described in § 112.5 – 112.7 Not applicable (FTR does not include the concept of “qualified end-users”)
Produce farms with average annual sales of produce of $25,000 or less, adjusted for inflation with 2011 as the baseline year (as described in the PSR) Farm is not covered

Farm is exempt.

The FTR specifically adopted this PSR exemption, even though it includes a 2011 baseline year, to provide assurance that any produce farm that isn’t covered by the PSR due to § 112.4(a) is also exempt from the FTR.
Produce farms with average annual sales of produce of $25,000 or less, adjusted for inflation with 2020 as the baseline year Not relevant, because the PSR uses 2011 as the baseline year – see previous row

Farm is exempt.

The FTR includes this exemption for consistency with other size-based exemptions to the FTR, which use 2020 as the baseline year. This exemption will often overlap with the exemption described in the previous row.
Food is sold or donated directly to the consumer by the farm that produced the food Not applicable Food is exempt
Food [including produce] produced and packaged on a farm Not applicable Food [including produce] is exempt, provided that:
  1. The packaging of the food remains in place until the food reaches the consumer, and such packaging maintains the integrity of the product and prevents subsequent contamination; and
  2. The labeling of the food that reaches the consumer includes the name, complete address, and business phone number of the farm.
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